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Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19

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ClinicalTrials.gov Identifier: NCT04913675
Recruitment Status : Active, not recruiting
First Posted : June 4, 2021
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE May 27, 2021
First Posted Date  ICMJE June 4, 2021
Last Update Posted Date September 24, 2021
Actual Study Start Date  ICMJE June 10, 2021
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
Proportion of participants who have progression of COVID-19 [ Time Frame: Up to Day 29 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • Occurence of of adverse events (AEs) [ Time Frame: Up to 24 weeks ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: Up to 24 weeks ]
  • Occurrence of adverse events of special interest (AESI) [ Time Frame: Up to 24 weeks ]
  • Incidence (if applicable) of serum anti-drug antibody (ADA) to sotrovimab [ Time Frame: Up to 24 weeks ]
  • Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab [ Time Frame: Up to 24 weeks ]
  • Cmax (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • Cmax (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • Clast (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • Clast (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • Tmax (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • Tmax (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • Tlast (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • Tlast (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • AUCinf (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • AUCinf (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • AUClast (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • AUClast (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • %AUCextrap (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • %AUCextrap (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • t1/2 (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • t1/2 (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • Vz/F (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • Vz/F (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • CL/F (intravenous infusion) [ Time Frame: up to 24 weeks ]
  • CL/F (intramuscular injection) [ Time Frame: up to 24 weeks ]
  • Mean area under the curve of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) viral load in nasal secretions as measured by qRT-PCR [ Time Frame: Up to Day 8 ]
  • Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR [ Time Frame: Up to Day 8 ]
  • Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR) [ Time Frame: Up to Day 8 ]
  • Proportion of participants who progress to develop severe and/or critical respiratory corona virus disease- 2019 (COVID-19) as manifest by requirement for and method of supplemental oxygen [ Time Frame: Up to Day 29 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19
Official Title  ICMJE A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients.
Brief Summary A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: VIR-7831
    500mg IV
  • Biological: VIR-7831
    500mg IM
  • Biological: VIR-7831
    250mg IM
Study Arms  ICMJE
  • Active Comparator: VIR-7831 (Sotrovimab) 500mg IV
    VIR-7831 given by intravenous infusion
    Intervention: Biological: VIR-7831
  • Experimental: VIR-7831 (Sotrovimab) 500mg IM
    VIR-7831 given by intramuscular injection
    Intervention: Biological: VIR-7831
  • Experimental: VIR-7831 (Sotrovimab) 250mg IM
    VIR-7831 given by intramuscular injection
    Intervention: Biological: VIR-7831
Publications * Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2021)
1020
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 29, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must be aged 12 years or older at time of consent AND at high risk of progression of COVID-19 or ≥ 55 years old
  • Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 7 days from onset of symptoms

Exclusion Criteria:

  • Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
  • Symptoms consistent with severe COVID-19
  • Participants who, in the judgement of the investigator are likely to die in the next 7 days
  • Known hypersensitivity to any constituent present in the investigational product
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Ukraine,   United States
Removed Location Countries Argentina,   Austria,   Canada,   India,   Italy,   Peru
 
Administrative Information
NCT Number  ICMJE NCT04913675
Other Study ID Numbers  ICMJE VIR-7831-5008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vir Biotechnology, Inc.
Study Sponsor  ICMJE Vir Biotechnology, Inc.
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE Not Provided
PRS Account Vir Biotechnology, Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP